Novel Antimicrobials and AMR Diagnostics 2019

News

FDA finalizes guidance on development of AST

FDA has finalized its guidance on how to coordinate development of antimicrobials and ASTs. In February, a webinar will take place.

In the antimicrobial resistance field, there remains scope to better synchronize development of antimicrobial medicines and antimicrobial susceptibility tests (ASTs).

AST devices, such as qualitative disc diffusion and elution tests, play an important role by providing insights into the susceptibility of bacterial pathogens to drugs. Equipped with these test results, physicians can make informed treatment decisions and thereby cut the time it takes to provide effective treatment. However, in some cases development of an AST device only starts as a drug nears approval, or even after it has come to market. This asynchronous development creates periods in which new drugs are available but physicians lack devices to show whether they will work for particular patients.

FDA now wants more coordination in early development phases. By involving test developers early, FDA thinks drug companies can use trials to generate isolates and information that support the creation of AST devices, and in turn benefit from the availability of tests that aid development. A draft was released in 2016 and a public workshop was held. 

Having finalized the guidance, FDA now plans to host a webinar on February 12 to discuss its implications for developers of AST devices and antimicrobial drugs.

For more information about the finalized guidance

For more information about the webinar